Tezepelumab 210mg/1.91ml solution for injection pre-filled disposable devices

Background: Tezepelumab is a human thymic stromal lymphopoietin (TSLP) antibody with effects in asthma. Therefore, our study aimed to evaluate the overall efficacy and safety of tezepelumab for the treatment of uncontrolled asthma. Methods: The databases Cochrane Library, PubMed, Embase, Web of Science, and Clinical Trials were searched from inception to April 1, 2022. Only randomized controlled trial (RCTs) that evaluated tezepelumab and a comparator for treating uncontrolled asthma were included. Additionally, articles were limited to English. The primary outcome was clinical efficacy, and the secondary outcome was adverse events. The risk of bias and quality were assessed by the Cochrane Collaboration bias assessment tool. The meta-analysis was performed using Review Manager Version 5.3. Results: Four RCTs with a total of 1600 patients were included in the study. Pooled analysis indicated that tezepelumab had significantly decreased annualized asthma exacerbations (odds ratio [OR] = 0.67, 95% confidence interval [CI] = [0.57, −0.80], P < .00001) and the asthma control questionnaire score of 6 (ACQ-6) among the patients (standard mean difference [SMD] = −0.29, 95% CI = [−0.39, −0.20], P < .00001) compared to placebo. Furthermore, tezepelumab treatment significantly improved forced expiratory volume in 1 second (FEV1, SMD = 0.28, 95% CI = [0.11, 0.45], P = .001). Regarding safety, the pooled analysis indicated that patients treated with tezepelumab showed no significant difference in adverse events that led to discontinuation of the treatment, but they experienced some other (non-serious) adverse events compared to the placebo group. However, there was a significant decrease in the incidence of serious adverse events and any adverse events in the tezepelumab group. Tezepelumab use was associated with adverse events, including nasopharyngitis, headache, and bronchitis, despite effectively treating asthma. Conclusion: Tezepelumab effectively improved FEV1, reduced the disease symptom score, and decreased the risk of exacerbations in uncontrolled asthma patients. Tezepelumab was associated with some adverse events compared to placebo. This suggests that careful management of adverse events is required if tezepelumab is used to treat asthma patients.

Abstract licence: CC BY-NC 4.0

BACKGROUND: Asthma patients with comorbid chronic rhinosinusitis or nasal polyps (CRS/NP) often experience poor asthma control. However, the comparative efficacies of biological therapies in this subgroup remain unclear. METHODS: A comprehensive search of multiple databases was conducted to identify randomized controlled trials (RCTs) on biological therapies targeting uncontrolled asthma that included CRS/NP data. The outcomes of interest were annual asthma exacerbation rate (AER), pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1), asthma control questionnaire (ACQ) scores, and sinonasal outcome test (SNOT-22) scores. Pairwise meta-analyses were performed based on the presence or absence of CRS/NPs. Subsequently, random-effects network meta-analyses were conducted to perform indirect comparisons of the individual biological therapies. RESULTS: Eleven eligible RCTs evaluating tezepelumab, dupilumab, mepolizumab, and benralizumab were identified. Omalizumab and reslizumab were excluded because subgroup data were not available. Pairwise meta-analyses demonstrated significantly greater improvement effects of biological therapies on all outcomes in patients with CRS/NP than in those without CRS/NP (p < 0.01). In the network meta-analyses, for CRS/NP patients, tezepelumab showed the most pronounced reduction in AER (rate ratio 0.17; 95% confidence interval [CI] 0.09, 0.29), while benralizumab (mean difference [MD] 0.30 L; 95% CI 0.19, 0.40) exhibited the greatest improvement in pre-BD FEV1. Tezepelumab demonstrated the most substantial improvement in the ACQ scores (MD -0.80; 95% CI -1.25, -0.35), whereas mepolizumab (MD -11.80; 95% CI -19.75, -3.85) was associated with the greatest improvement in the SNOT-22 scores. CONCLUSIONS: In the management of asthma with CRS/NP, it is crucial to select biological therapies that consider specific improvements in individual outcomes.

Abstract licence: CC BY-NC-ND

Abstract Background Chronic rhinosinusitis (CRS) is a highly prevalent inflammatory condition of the paranasal sinuses and nasal cavities, which affects 5% to 28% of the general population and can have a profound impact on quality of life. Aim and objectives To evaluate the effectiveness of Tezepelumab during the first year of treatment of Chronic rhinosinusitis with nasal polyps, focusing on improvement in Sino-Nasal Outcome Test. Subjects and methods This systematic review and meta-analysis study contained 4 studies (Laidlaw et al., 2023, Emson et al., 2021, Jacobs et al., 2024 and Lipworth et al., 2025). Result The pooled analysis of the SNOT-22 total score highlighted a significant reduction in scores, indicating improved patient outcomes. The combined effect size showed MD of -9.31, with CI from -15.17 to -3.46. This suggests a notable decrease in SNOT-22 scores, reflecting better symptom management. The overall effect yielded a Z value of 2.39, confirming the significant reduction in SNOT-22 scores. Conclusion This meta-analysis demonstrates that Tezepelumab significantly reduces annualized asthma exacerbation rates (AAER) and improves asthma control, as evidenced by the substantial reduction in Asthma Control Questionnaire (ACQ -6 scores). Additionally, there is a notable improvement in symptom burden, reflected by decreased SNOT-22 scores, indicating enhanced quality of life. Although no significant change was observed in pre-bronchodilator (FEV1), suggesting limited effect on baseline lung function, the overall findings support the effectiveness of Tezepelumab in improving clinical outcomes in asthma. Furthermore, evidence from recent clinical trials shows that Tezepelumab is also effective in the treatment of chronic rhino sinusitis with nasal polyps (CRSwNP). These results reinforce Tezepelumab’s role as a promising therapeutic option in the management of both severe asthma and chronic rhino sinusitis with nasal polyps (CRSwNP), although further research is warranted to better understand variability across patient populations and optimize treatment strategies.

Abstract licence: CC BY 4.0

ObjectiveCurrent biological treatments are not suitable for many patients with severe asthma. The aim of this meta-analysis was to determine the efficacy of tezepelumab in patients with asthma.MethodsThe authors conducted systematic searches of PubMed, Embase, the Cochrane Library, and clinicaltrials.gov without language restrictions. Randomized Controlled Trials (RCTs) on treatment of asthma with tezepelumab were reviewed. The authors summarized findings as Risk Ratios (RR) for dichotomous outcomes and Weighted Mean Differences (WMD) for continuous outcomes, each with 95% Confidence Intervals (95% CI).ResultsSeven RCTs (enrolling 2050 participants) met the inclusion criteria. Tezepelumab showed significant effects on asthma exacerbation (RR = 0.72, 95% CI 0.65% to 0.80), percentage change in Forced Expiratory Volume in 1 s (FEV1) (WMD = 7.97%, 95% CI 3.10% to 13.83%), percentage change in Forced Vital Capacity (FVC) (WMD = 3.80%, 95% CI 2.48% to 5.12%), Asthma Control Questionnaire (ACQ)-6 score (WMD = -0.35, 95% CI -0.45 to -0.25), Asthma Quality of Life Questionnaire (standardized) for patients 12-years of age or older (AQLQ[S]+12) score (WMD = 0.33, 95% CI 0.22 to 0.43), and serious adverse events (RR = 0.74, 95% CI 0.57 to 0.95).ConclusionsTezepelumab appears safe and effective; further long-term and real-world studies are warranted.

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BackgroundAsthma is a heterogeneous inflammatory disease that can cause substantial morbidity, reduced quality of life, and socioeconomic burden when uncontrolled. Biologic therapies have become central to the management of moderate-to-severe asthma by targeting specific inflammatory pathways.MethodsThis overview of systematic reviews synthesized evidence on the efficacy and safety of biologic agents for uncontrolled asthma. Searches were conducted in Medline (PubMed), Embase, LILACS, Web of Science, and the Cochrane Library using MeSH and Emtree terms structured according to the PICOT framework. Systematic reviews with meta-analyses or network meta-analyses comparing omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab were included.ResultsIn indirect comparisons, dupilumab and tezepelumab were associated with more favorable outcomes in reducing the annualized exacerbation rate (AER) than benralizumab, mepolizumab, and reslizumab in severe uncontrolled asthma. In eosinophilic asthma, indirect evidence suggested more favorable outcomes with mepolizumab, tezepelumab, and dupilumab across eosinophil-defined subgroups (≥ 400 cells/μL, ≥ 300 cells/μL, ≥ 150 cells/μL, and 1), indirect evidence suggested more favorable outcomes with dupilumab. Regarding asthma control (ACQ), more favorable outcomes were observed with mepolizumab in specific comparisons. Regarding quality of life (AQLQ), more favorable outcomes were observed with omalizumab and tezepelumab in the general and eosinophilic asthma populations, respectively. One indirect comparison suggested lower odds of serious adverse events with mepolizumab.ConclusionThe available evidence suggests that biologic therapies may be effective and generally safe options for uncontrolled asthma, although the methodological quality of most included reviews was critically low. These findings support individualized treatment guided by biomarkers and clinical characteristics and highlight the need for standardized, methodologically rigorous future studies.

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Background and Objectives: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous type 2 inflammatory disease for which biologic therapies have expanded treatment options; however, biomarkers capable of guiding biologic selection remain poorly defined. This systematic review aimed to evaluate the available evidence regarding predictive and prognostic biomarkers associated with currently available biologic agents for CRSwNP (omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, and tezepelumab). Materials and Methods: A systematic search of PubMed/MEDLINE, Embase, Google Scholar, and the Cochrane Library identified studies published between January 2006 and September 2025. Results: Twenty-five eligible studies, including 12 randomized controlled trials, 12 systematic reviews/meta-analyses, and one indirect treatment comparison study, were analyzed. Multiple biomarkers, including blood eosinophils, total IgE, periostin, eotaxins, eosinophil cationic protein, IL-5, TARC, PARC, and urinary leukotriene E4, were evaluated across biologics targeting IgE, IL-4/IL-13, and IL-5 pathways. Conclusions: Although several biomarkers reflected the modulation of type 2 inflammation and disease activity, no validated biomarker has reliably predicted the superiority of one biologic over another. Nasal IL-5 showed potential for predicting the response to anti-IL-5 therapy but requires further validation. Current evidence supports biomarker use primarily for confirming type 2 inflammation rather than guiding biologic selection. Prospective biomarker-driven and head-to-head comparative studies are needed to enable precision medicine approaches in CRSwNP.

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Background: Airway mucus plugging is a key but long-overlooked mechanism of persistent airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Type 2 (T2) cytokines, particularly interleukin (IL)-4 and IL-13, drive goblet cell metaplasia, MUC5AC overexpression, and impaired mucociliary clearance, while eosinophil-derived products increase mucus viscosity and promote plug persistence. Methods: A comprehensive narrative review was conducted by searching PubMed and ClinicalTrials.gov databases from inception to February 2026. Search terms included "mucus plugs," "mucus plugging," "biologics," "dupilumab," "tezepelumab," "mepolizumab," "benralizumab," "IL-4," "IL-13," "MUC5AC," "quantitative CT," "functional respiratory imaging," "asthma," and "COPD." Studies were included if they reported original data or systematic evidence on mucus plug quantification, biologic-mediated changes in mucus plug scores, or imaging modalities for mucus assessment in asthma or COPD. Editorials, case reports with fewer than three patients, and studies not available in English were excluded. Two authors (P.-V.M. and A.C.) independently screened titles and abstracts; discrepancies were resolved by consensus. Randomized controlled trials, observational studies, and preclinical studies evaluating mucus plug outcomes and T2-targeted therapies were included. Reference lists of retrieved articles were hand-searched for additional relevant publications. Results: A recent systematic review identified multiple randomized controlled trials and observational studies that showed CT-assessed mucus plug scores go down with biologic therapies targeting the T2 pathway in asthma. Observational data extend this evidence to anti-IL-5/IL-5Rα agents. The VESTIGE trial provided the first functional respiratory imaging evidence of mucus plug resolution with dupilumab. In COPD, the BOREAS/NOTUS and MATINEE trials established the efficacy of dupilumab and mepolizumab in eosinophilic phenotypes; however, differences in inclusion criteria-particularly regarding FeNO thresholds and prior exacerbation burden-may explain divergent effects on lung function endpoints. Mucus plug outcomes have not been evaluated in COPD biologic trials. Quantitative imaging modalities, including HRCT mucus plug scoring, functional respiratory imaging, and hyperpolarized gas MRI, now enable objective assessment of mucus burden. Conclusions: Mucus plugging meets the definition of a treatable trait: it can be measured with CT scoring, it matters clinically, and it responds to T2 cytokine blockade. Adding mucus plug assessment to routine clinical evaluation, together with mucolytic strategies where needed, could move treatment decisions from empirical to biology-based across the asthma-COPD spectrum. Further studies are needed to confirm that mucus plug scoring works as a biomarker of treatment response in COPD and to test whether combining biologics with mucolytics improves outcomes.

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